Adenovirus types 5 and 35 seroprevalence in AIDS risk groups supports type 35 as a vaccine vector

S Kostense, W Koudstaal, M Sprangers, GJ Weverling… - Aids, 2004 - journals.lww.com
S Kostense, W Koudstaal, M Sprangers, GJ Weverling, G Penders, N Helmus, R Vogels…
Aids, 2004journals.lww.com
25–100 cm3). Grade 2 injection site reactions in the two subjects occurred after only one of
the four injection series for each subject. In each individual subject, injection site reactions
did not occur with each series of injections. The one subject in cohort III who received a
higher dose of IL-12 developed grade 1 injection site symptoms and body aches with the
first injection series, grade 1 fever and grade 2 body aches and chills with the second
injection series, but only grade 1 body aches with the third injection series. No ulcerations …
25–100 cm3). Grade 2 injection site reactions in the two subjects occurred after only one of the four injection series for each subject. In each individual subject, injection site reactions did not occur with each series of injections. The one subject in cohort III who received a higher dose of IL-12 developed grade 1 injection site symptoms and body aches with the first injection series, grade 1 fever and grade 2 body aches and chills with the second injection series, but only grade 1 body aches with the third injection series. No ulcerations, necrosis, or sterile abscesses were seen in any subject. Grade 1 or 2 systemic symptoms consisting of fever, chills, headache or body aches occurred in three subjects, two in cohort I and one in cohort III. Grade 3 bilirubin and alanine/aspartate aminotransferase elevations occurred in one subject with chronic active hepatitis C, who had grade 2 elevations at baseline.
Previously, DATRI 010 examined the safety and immunogenicity of the C4-V3 vaccine (2.0 mg total peptide) in 10 HIV-infected subjects [1]. Five out of eight C4-V3 recipients had LPA responses that increased fivefold or more over the baseline SI to at least one of the immunogen peptides in two consecutive post-immunization timepoints compared with none of the two controls who received IFA alone. Three out of eight vaccine recipients had fivefold or greater increases to all four peptides. In our study, increased lymphocyte proliferation responses were seen in six out of nine subjects, of which four subjects developed stimulation indices threefold or greater above baseline on two consecutive visits against all four peptides. Given our small numbers, no statistically significant effect of IL-12 could be demonstrated; however, there appeared to be a trend towards increasing LPA responses with the receipt of IL-12.
Lippincott Williams & Wilkins